Last week, the U.S. Food and Drug Administration (FDA) granted marketing authorization for 23andMe’s Personal Genome Service (PGS) Test for 10 diseases or conditions. This was the first FDA authorization for a...more
Last Thursday the genetic diagnostic and DNA analysis company 23andMe announced that the FDA had granted the company approval to market a genetic diagnostic test for Bloom's Syndrome, the first such approval for this rare...more
23andMe is not a traditional diagnostics company. Rather than seeking to directly sell its services to health care professionals, 23andMe went straight to the consumer, offering genetic screening and analysis in a mail-order...more